A trial investigating pregnancy and infant outcomes in women with intrahepatic cholestasis of pregnancy treated with ursodeoxycholic acid or placebo.

Phase 3

Completed

• Conditions: Intrahepatic Cholestasis of Pregnancy; Pregnancy and Childbirth

• Registration Number: ISRCTN91918806
• Lead Sponsor: King's College London

Brief Summary

2018 Protocol article in https://www.ncbi.nlm.nih.gov/pubmed/30482254 protocol 2019 Results article in https://www.ncbi.nlm.nih.gov/pubmed/31378395 results (added 06/08/2019) 2020 Other publications in https://pubmed.ncbi.nlm.nih.gov/33063439/ secondary analysis (added 22/10/2020) 2020 Results article in https://doi.org/10.3310/eme07090 (added 12/09/2023)

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2015-08-27
• Study Completion: 2019-02-28
• Last Update Posted: 26 September 2023

Recruitment & Eligibility

• Status: Completed
• Sex: Female
• Target Recruitment: 605

Inclusion Criteria

1. ICP (pruritus with a raised serum bile acid above the upper limit of normal for the local laboratory)
2. 20+0 to 40+6 weeks' gestation on day of randomisation
3. No known lethal fetal anomaly
4. Singleton or twin pregnancy
5. Aged 18 years or over
6. Able to give written informed consent

Exclusion Criteria

1. Decision has already made for delivery within the next 48 hours
2. Allergy to any component of the UDCA or placebo tablets
3. Triplet or higher-order multiple pregnancy

Study & Design

• Study Type: Interventional
• Study Design: Not specified